The Recall Desk

FDA (Devices) recall action 85077

Boston Scientific Corporation recalled 2 products on 2020-03-25

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-03-25
Critical
0
Units
5

Why these products were recalled

Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2020-03-25

    Boston Scientific LATITUDE Programming System Software Update Recall

    Boston Scientific is recalling four LATITUDE Programming System devices that downloaded unapproved software applications.

    Product
    Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all commu
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2020-03-25

    Boston Scientific DYNAGEN EL ICD DR Recall for Unapproved Software

    Boston Scientific is recalling one DYNAGEN EL ICD DR device because a software update downloaded unapproved applications to four programmers.

    Product
    Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of lif
    Category
    Distribution
    3 states